Safety Report ID 15404701

Responsible use of the data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product.

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. In recent years the FDA has undertaken efforts to increase collection of adverse events. Increases in the total number of adverse events is likely caused by improved reporting.

Disclaimer

FAERS data does have limitations. There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event.

Further, FDA does not receive reports for every adverse event or medication error that occurs with a product. Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.

Submission of a safety report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer or product caused or contributed to the event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.

Drug Adverse Report

Safety Report ID

15404701

The 8-digit Safety Report ID number, also known as the case report number or case ID. The first 7 digits (before the hyphen) identify an individual report and the last digit (after the hyphen) is a checksum. This field can be used to identify or find a specific adverse event report.

Receive Date

09/19/2018

Date that the report was first received by FDA. If this report has multiple versions, this will be the date the first version was received by FDA.

Occur Country

US

The name of the country where the event occurred.

Seriousness of the adverse event

Other

Seriousness of the adverse event

Patient Information

Patient Sex

Male

The sex of the patient:

Unknown

Male

Female

Patient Age

N/S (not specified)

Age of the patient when the event first occured.

Patient Age Unit

N/S (not specified)

The unit for the interval in the field 'patientage'.

Decade

Year

Month

Week

Day

Hour

Patient Age Group

N/S (not specified)

Populated with Patient Age Group code:

Neonate

Infant

Child

Adolescent

Adult

Elderly

Patient Weight

N/S (not specified)

The patient weight, in kg (kilograms).

Patient Reaction(s)

#

Reaction MedDRA

Reaction Outcome

1

Dementia

Unknown

2

Psoriasis

Unknown

3

Intracranial mass

Unknown

Drug #1

Date the patient began taking the drug and date the patient stopped taking the drug: -

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